Tuesday, January 18, 2011

Second read of the initial New York Times article published on 3/9/10


Some orthopedic experts, as reported in this story, had voiced dismay in recent interviews that Depuy had not halted the sales of the device earlier. The article mentioned that Dr. Stephen Graves (Director of the implant data base in Australia) said the data had shown for some time that the hip had been failing at a significantly higher rate than some competitors.  In December of 09, Depuy withdrew the hip from the Australian marke.t

I must have missed the graph the first time around with data from the FDA for the US. 

Between 2006 and 2009, problems with the Depuy hip device rose sharply: Over 90% required replacement (Source: FDA)



06
07
08
09
All reports of problem hips. 90% required replacement
20
80
225
300
Percent increase in the problems

300%
181%
33%


It took 3 years before Depuy issued a recall (end of 2010) in the US after it sent warnings to the Orthopedic Surgeons in March of 2010 advising that the Australian data suggested a higher-than-expected failure rate.
Depuy’s representative, Sally Hunter, the world wide vp for regulatory affairs made the following observations:
·         Some problems with the hip had arisen because doctors were improperly implanting the device’s cup when first using it. [We know now that it has to be placed at a 45 degree angle.]
·         With every device there is a learning curve she said.
In another statement, Depuy stated that while there is a theoretical potential for the hip cups to be sensitive to position placement, other data does not support the fact that performance is primarily related to design.  In early 2009 however, Depuy sent a brochure to doctors on the importance of proper cup positioning for all hip implants but did not specifically mention the ASR model which was the one recalled in 2010.
The hip co-developer, Dr. Schmalzried, an Orthopedic surgeon in LA said that he and Depuy officials realized within the last two years that the cup might be more challenging to implant than competing cups.
When Depuy was asked by reporters what they thought of Dr. Schmalzried’s comments, Depuy expressed surprise that he had made them.

connie

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